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Device, catheter for crossing total occlusions. Regulation Description, Percutaneous catheter. Definition, To facilitate the intraluminal placement of conventional guidewires beyond stenotic lesions (including subchronic and chronic total occlusions) in the peripheral vasculature prior to further percutaneous intervention, such
Physical State, metal guidewire with or without polymer coating, and associated guidewire accessories Note: Class II devices the Food and Drug Administration (FDA) has also published a list of class II (special controls) devices9 subject to certain limitations, that are exempt from premarket notification requirements under
29 Jun 2017 The device may contain syringes, needles, and drugs. 17. Angiographic. Guide. Wire and Accessories. Class B It delivers radio opaque media and therapeutic agents to selected sites in the vascular system. It is also used to lead a guide wire or a catheter into the target site. 18. Cardiac Catherization. Kit.
Product, FindrWIRZ Guidewire System Catalog# 40-05. Cardiology: The system is intended for use in the cardiovascular system for introduction and positioning of over the-wire catheters and therapeutic devices during interventional procedures. Code Information, Lot# 01160568 . Lot#02160586, (no products shipped from
CHAPTER I--FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN (a) Identification. A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel. (b) Classification. Class II (performance standards).
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23 Nov 2016 SentreHeart has issued a recall of its FindrWIRZ Guidewire System because of concerns that its polytetrafluoroethylene (PTFE) coating may peel or flake off, possibly leading to injury if the broken pieces travel through the body, according to a statement released by the US Food and Drug Administration
The filter or balloon is used to capture embolic material in a manner that may protect or prevent a stroke or other cerebral vascular sequelae. The embolic capture device is indicated for use as a guidewire and embolic protection system to contain and remove embolic material (thrombus/debris) while performing angioplasty
Device, wire, guide, catheter. Regulation Description, Catheter guide wire. Regulation Medical Specialty, Cardiovascular. Review Panel, Cardiovascular. Product Code, DQX. Premarket Review, Office of Device Evaluation 6 (ODE) Division of Cardiovascular Devices (DCD) Peripheral Interventional Devices Branch (PIDB).
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